NCT04279834Completed
Improving Outcomes for Patients With SDB and Insufficient Sleep
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness. In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 561 (actual)
- First submitted
- 19 Feb 2020
- Start date
- 16 Oct 2020
- Primary completion date
- 11 Aug 2025
- Lead sponsor
- Wayne State University
- Diseases
- High blood pressure
- NCT number
- NCT04279834
What you commit to
- Study type: Interventional
- Participants enrolled: 561
- From 16 Oct 2020 to the primary completion date, 11 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of PAP or oral appliance therapy for SDB
- A recent health event that may affect sleep (e.g. recent surgery or hospitalization)
- Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range.
Other illness
- Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)
- Current alcohol or substance use disorder (\<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis)
- Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and
Other
- Pregnancy or within 6 months post-partum
- Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS\>18
- Central sleep apnea (defined as central apnea/hypopnea index \>5, and \>50% of total AHI).
Who the study is looking for
- Over age 18 years
- Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)
- Additional Inclusion Criteria for randomization will be:
- ESS score \>6
- Total sleep time \<7 hours at least 4 nights per week, based on baseline sleep diary.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.